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NCT03446573 · ClinicalTrials.gov registry record · Phase 3
Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 743
- Enrollment target
NCT03446573 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 743 participants.
The verdict
NCT03446573, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 743 participants
- Enrollment target
Study Summary
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a \>=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200. This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.
Interventions
- DRUG DTG + 3TC
- DRUG TAF based regimen (TBR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03446573
The ClinicalTrials.gov registry entry for NCT03446573 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 743 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DTG + 3TC is the first listed.
NCT03446573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03446573 about?
NCT03446573 is a clinical study titled "Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)". The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a \>=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram ...
What is the current status of trial NCT03446573?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2018-01-18. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT03446573?
The interventions under investigation include: DTG + 3TC (DRUG), TAF based regimen (TBR) (DRUG).
Who is sponsoring clinical trial NCT03446573?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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